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DEVELOPMENT AND VALIDATION OF AN ENZYME-LINKED IMMUNOASSAY KIT FOR DIAGNOSIS AND SURVEILLANCE OF COVID-19.
Bagno, Flávia F; Sérgio, Sarah A R; Figueiredo, Maria Marta; Godoi, Lara C; Andrade, Luis A F; Salazar, Natália C; Soares, Camila P; Aguiar, Andressa; Almeida, Flávia Jaqueline; da Silva, Edimilson D; Ferreira, Antônio G P; Durigon, Edison Luiz; Gazzinelli, Ricardo T; Teixeira, Santuza M R; Fernandes, Ana Paula S M; da Fonseca, Flavio G.
  • Bagno FF; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • Sérgio SAR; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
  • Figueiredo MM; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • Godoi LC; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • Andrade LAF; Universidade Estadual de Minas Gerais, Divinópolis, MG, Brazil.
  • Salazar NC; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • Soares CP; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • Aguiar A; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • Almeida FJ; Universidade de São Paulo (USP), Instituto de Ciências Biomédicas, São Paulo, SP, Brazil.
  • da Silva ED; Geriatric and Convalescent Hospital Dom Pedro II, São Paulo, SP, Brazil.
  • Ferreira AGP; Department of Pediatrics, Santa Casa de São Paulo School of Medical Sciences, São Paulo, SP, Brazil.
  • Durigon EL; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
  • Gazzinelli RT; Fundação Oswaldo Cruz-Fiocruz, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.
  • Teixeira SMR; Universidade de São Paulo (USP), Instituto de Ciências Biomédicas, São Paulo, SP, Brazil.
  • Fernandes APSM; Centro de Tecnologia de Vacinas (CT Vacinas), BH-Tec, UFMG. Belo Horizonte, MG, Brazil.
  • da Fonseca FG; Fundação Oswaldo Cruz-Fiocruz, Centro de Pesquisas René Rachou, Belo Horizonte, MG, Brazil.
J Clin Virol Plus ; : 100103, 2022 Aug 17.
Article in English | MEDLINE | ID: covidwho-2028189
ABSTRACT
There is a massive demand to identify alternative methods to detect new cases of COVID-19 as well as to investigate the epidemiology of the disease. In many countries, importation of commercial kits poses a significant impact on their testing capacity and increases the costs for the public health system. We have developed an ELISA to detect IgG antibodies against SARS-CoV-2 using a recombinant viral nucleocapsid (rN) protein expressed in E. coli. Using a total of 894 clinical samples we showed that the rN-ELISA was able to detect IgG antibodies against SARS-CoV-2 with high sensitivity (97.5%) and specificity (96.3%) when compared to a commercial antibody test. After three external validation studies, we showed that the test accuracy was higher than 90%. The rN-ELISA IgG kit constitutes a convenient and specific method for the large-scale determination of SARS-CoV-2 antibodies in human sera with high reliability.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Prognostic study Language: English Journal: J Clin Virol Plus Year: 2022 Document Type: Article Affiliation country: J.jcvp.2022.100103

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Prognostic study Language: English Journal: J Clin Virol Plus Year: 2022 Document Type: Article Affiliation country: J.jcvp.2022.100103